Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy

Andrew Bernard

Status: Completed

Conditions: Negative Pressure Wound Therapy; Abdominal Injury; Fistula

Treatments: Device: 3D printed EAF management device

Study type: Interventional

Funder types: Other

Identifiers

NCT04978090

46641

Details and patient eligibility

About

This study aims to assess the efficacy of a custom fitted device designed to isolate enteroatmospheric fistulas effluent independent of negative pressure wound therapy and to evaluate the effects on the device related to dressing changes, time required for dressing changes, management costs, and the ease of use.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Stable condition, as determined by attending physician
• Has enteroatmospheric fistula (EAF) in the setting of open abdomen
• EAF is determined to require surgical resolution

Exclusion criteria

• Unstable condition, as determined by attending physician
• Significant risk of complication

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Enteroatmospheric fistula (EAF) management solution

Experimental group

Description:

Participants will receive a custom fitted device designed to isolate EAF effluent independent of negative pressure wound therapy (NPWT) utilizing 3D printing technology to design a participant-matched device that more easily and effectively separates the participant's fistula and any emanated intestinal contents surrounding the wound.

Treatment:

Device: 3D printed EAF management device